Clean Room

Personnel Protective EquipmentTechnologists wear particle free scrubs and don clean room apparel prior to entering the lab. Personnel protective equipment (PPE) provides protection from products that may pose a biohazard risk, while minimizing the amount of particulates that might be shed by the technologist.

Class 10,000 / ISO 7 Clean Room Facility

ISO 7 clean room facilities are strictly monitored to ensure that maximum particle counts do not exceed 10,000 particles (Sized: 0.5 micrometers or larger) per cubic foot of air. Minimizing particulates in the environment decreases the risk of contamination.

Biological Safety Cabinets BSCs are designated for one patient product and are cleaned before and after each use.

The biological safety cabinet (BSC) is designed to protect the environment and technologist from biological hazards and contaminates Products are processed in class 100 / ISO 5 biological safety cabinets. This provides a working environment where maximum particle counts do not exceed 100 particles (Sized: 0.5 micrometers or larger) per cubic foot of air.

Aseptic Technique

In order to maintain sterility, technologists process using aseptic technique. Care must be taken to reduce the risk of contamination and prevent the transfer of organisms.

Environmentals

Technologists use touch plates on both their gloves and the BSC surface post processing to ensure that aseptic technique is being followed.

Handheld particle counters are used to monitor the environment on a set weekly schedule.

Touch Plates Handheld Particle Counter

Contamination Control Cleaning

The lab is cleaned nightly by a professional contamination control specialist using particle free equipment, and appropriate clean room decontamination solutions.